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Screening strategy to advance HCV elimination in Italy: a cost-consequence analysis

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Abstract

Background and Aims

Italy has the greatest burden of hepatitis C virus (HCV) infection in Western Europe. The screening strategy represents a crucial prevention tool to achieve HCV elimination in Italy. We evaluated the cost-consequences of different screening strategies for the diagnosis of HCV active infection in the birth cohort 1948–1968 to achieve the HCV elimination goal.

Methods

We designed a probabilistic model to estimate the clinical, and economic outcomes of different screening coverage uptakes, considering the direct costs of HCV management according to each liver fibrosis stage, in the Italian context. A decision probabilistic tree simulates 4 years of HCV testing of the 1948–1968 general population birth cohort, (15,485,565 individuals to be tested) considering different coverage rates. A No-screening scenario was compared with two alternative screening scenarios that represented different coverage rates each year: (1) Incremental approach (coverage rates equal to 5%, 10%, 30%, and 50% at years 1, 2, 3, and 4, respectively) and (2) Fast approach (50% coverage rate at years 1, 2, 3 and 4). Overall 106,200 cases were previously estimated to have an HCV active infection. A liver disease progression Markov model was considered for an additional 6 years (horizon-time 10 years).

Results

The highest increased number of deaths and clinical events are reported for the No-screening scenario (21,719 cumulative deaths at the end of ten years; 10,148 cases with HCC and/or 7618 cases with Decompensated Cirrhosis). Following the Fast-screening scenario, the reductions in clinical outcomes and deaths were higher compared with No-screening and Incremental-screening. At ten years time horizon, less than 5696 liver deaths (PSA CI95%: – 3873 to 7519), 3,549 HCC (PSA CI95%: – 2413 to 4684) and less than 3005 liver decompensations (PSA CI 95%: – 2104 to 3907) were estimated compared with the Incremental-scenario. The overall costs of the Fast-screening, including the costs of the DAA and liver disease management of the infected patients for 10 years, are estimated to be € 43,107,543 more than no-investment in screening and € 62,289,549 less compared with the overall costs estimated by the Incremental-scenario.

Conclusion

It is necessary to guarantee dedicated funds and efficiency of the system for the cost-efficacious screening of the 1948–1968 birth cohort in Italy. A delay in HCV diagnosis and treatment in the general population, yet not addressed for the HCV free-of-charge screening, will have important clinical and economic consequences in Italy.

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Data availability

LAK had full access to the real-life data of the PITER cohort used in the study. The aggregated data could be available upon request.

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Acknowledgements

Authors wish to thank the PITER collaborating group available at www.progettopiter.it. The PITER platform has been supported by Italian Ministry of Health Grant "Research Project PITER2010" RF-2010-2315839

Funding

This paper was supported by an unconditional grant from Gilead Italy.

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Author notes

  1. Andrea Marcellusi and Francesco Saverio Mennini equally contributed and should be considered as joint first authors.

Authors and Affiliations

  1. Faculty of Economics, CEIS, Economic Evaluation and HTA (EEHTA), University of Rome “Tor Vergata”, Rome, Italy

    Andrea Marcellusi & Francesco Saverio Mennini

  2. Institute for Leadership and Management in Health, Kingston University London, London, UK

    Francesco Saverio Mennini

  3. Center for Global Health, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy

    Loreta A. Kondili

  4. Policlinico Tor Vergata, University of Rome “Tor Vergata”, Rome, Italy

    Massimo Andreoni

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  1. Andrea Marcellusi
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  4. Loreta A. Kondili
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Consortia

PITER collaboration study group

Contributions

AM, FSM, MA and LAK designed the study. AM built the modelling and validated it. AM and LAK prepared the material, managed and analyzed the real-life cost of disease management, conducted the analysis and finalised the draft of the manuscript. AM, LAK and FSM provided guidance on the methodology, reviewed the results and critically assessed the manuscript. All of the authors reviewed the results of the final draft of the manuscript and approved the final version of the manuscript. LAK had full access to all the data used in the study and had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Loreta A. Kondili.

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Marcellusi, A., Mennini, F.S., Andreoni, M. et al. Screening strategy to advance HCV elimination in Italy: a cost-consequence analysis. Eur J Health Econ (2024). https://doi.org/10.1007/s10198-023-01652-0

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